Liposome formulation and manufacture
AssigneeBIOrest Ltd.
InventorsYoram RICHTER, Yehuda ZELIG, Omar ELMALAK, Dror EYAL
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Abstract
The present invention relates to a liposomal formulation containing a therapeutic agent and a process for producing the formulation. The liposomal formulation comprises particular characteristics that enhance uniformity and stability of the formulation. The manufacturing process is a novel process that produces a liposomal formulation of a uniform size with many desirable properties that may be independently controlled. Further, the invention relates to a liposome formulation made in accordance with the manufacturing process.
Claims36
A liposome having a lipid ingredient and encapsulating a therapeutic agent, having a mass ratio of said therapeutic agent to lipid of about 1:5 to 1:8, wherein the lipid ingredient comprises DSPC, DSPG and cholesterol in a molar ratio of about 3:1:2, and said liposome has compressibility less than 0.70 ml/g
A formulation comprising a plurality of liposomes, said liposomes having a lipid ingredient and a therapeutic agent, wherein the lipid ingredient comprises DSPC, DSPG and cholesterol in a molar ratio of about 3:1:2, and the formulation having a PDI less than 0.07.
A method of manufacturing a therapeutic formulation having a plurality of liposomes, said method comprising the following steps:
- (a) mixing a solution containing a therapeutic agent with a solution containing lipids comprising DSPC, DSPG and cholesterol in a molar ratio of about 3:1:2 to form vesicles such that the mass ratio of said therapeutic agent to lipid is in the range of about 1:5 to 1:8,
- (b) extruding the vesicles in a single stage through a filter having a pore size about 100 nm, and
- (c) ultrafiltrating the vesicles.
A formulation comprising a plurality of liposomes comprised of an amount of lipid ingredient and therapeutic agent, said lipid ingredient comprising DSPC, DSPG and cholesterol in a molar ratio of about 3:1:2, and the mass ratio of said therapeutic agent to lipid is in the range of about 1:5 to 1:8, said formulation manufactured by the following steps:
- (a) mixing a solution containing a therapeutic agent with a solution containing lipids comprising DSPC, DSPG and cholesterol in a molar ratio of about 3:1:2 to form vesicles such that the mass ratio of said therapeutic agent to lipid is in the range of about 1:5 to 1:8,
- (b) extruding the vesicles in a single stage through a filter having a pore size about 100 nm, and
- (c) ultrafiltrating the vesicles.
Dependencies are inferred from the claim text.